Drug substance and vaccine products are frequently provided in vials which are closed with an elastomer closure part through which a hollow needle can be passed, puncturing the closure part, and via which the drug substance or vaccine product may be extracted for use, optionally after reconstitution by an aqueous medium introduced into the vial via the needle. U.S. Pat. No. 5,718,348, DE-A-1228,028 and FR-A-2598137 among others, disclose typical pharmaceutical vials and closures. WO-A-04/018317 discloses a vial closure comprising an elastomer closure part for the mouth opening capable of being punctured by a needle, a clamp part to hold the closure part in a closing relationship with the mouth opening and having an aperture therein through which the closure part is exposed, and a cover part to cover the aperture when so engaged.
The vial closure disclosed in WO-A-04/018317 is particularly suited to a known process e.g. from US-A-2002/0023409 in which the vial can be filled, under aseptic filling conditions, using a hollow needle passed through the closure part, the needle is then withdrawn, and the small residual puncture hole is then sealed by heat sealing, e.g. using a focused laser beam.
In use, a removable part of the cover part of the vial closure disclosed in WO-A-04/018317 is removed to expose the closure part through the aperture, and a needle may be passed through the closure to extract the contents for use, typically by injection, optionally after reconstitution.